SERVICES

EQUIPMENT. We perform and execute all documents from the Plan Validation until the final report for each device / system. Extensive experience in packaging equipment, manufacturing, inhaled liquids, solid forms, syringes, etc.

FACILITIES. We have extensive experience in Purified Water, WFI, HVAC, Compressed air, Vacuum cleaning, etc. In short all installations involved in pharmaceutical production.

COMPUTER SYSTEMS VALIDATION. We perform validation of software systems, and automated systems. We also have experience in evaluation 21CFR11 Compliance.

EVALUATION AND VALIDATION OF EXCHANGE CONTROLS. not only equipment but complete GMP changes affecting the quality of the validated equipment

FACTORY ACCEPTANCE TEST. We check and review the status of newly acquired equipment in the manufacturing site, to meet customer requirements.

MAINTENANCE PLANS. Performing preventive maintenance plans for equipment ye facilities. Following a model FMEA, We perform maintenance wise for each team.

We have experience in software development for projects to improve maintenance management.

DEVELOPMENT OF STANDARDS. We made the rules of use of equipment. Information management standards. etc

MANAGEMENT SETTINGS We provide tailored solutions for calibration management team, maintenance management plans and risk assessment (quality and safety).

QUALITY ENGINEERING. We perform the upgrade of electrical and pneumatic diagrams.

CE Marking. Advise manufacturers to comply with the EC directive for new equipment and modified.

PROJECT MANAGEMENT INTEGRAL. Since the determination of requirements to implementation and validation.

TRAINING: Training for operators handling equipment.

Training in quality policies (GMP).

Training in the use of computer systems.